U.S. patent application number 17/308831 was filed with the patent office on 2021-08-19 for syringe support and autoinjector.
The applicant listed for this patent is Sanofi-Aventis Deutschland GmBH. Invention is credited to Thomas Mark Kemp, Carsten Mosebach.
Application Number | 20210252223 17/308831 |
Document ID | / |
Family ID | 1000005568555 |
Filed Date | 2021-08-19 |
United States Patent
Application |
20210252223 |
Kind Code |
A1 |
Mosebach; Carsten ; et
al. |
August 19, 2021 |
Syringe Support and Autoinjector
Abstract
The disclosure relates to a syringe support for supporting an
axial position of a syringe relative to a housing of an
autoinjector. The syringe support includes a supporting beam
arranged on the syringe support and biased radially inwards. The
supporting beam is adapted to axially bias the syringe in a distal
direction within the housing. The disclosure further relates to an
autoinjector.
Inventors: |
Mosebach; Carsten;
(Frankfurt am Main, DE) ; Kemp; Thomas Mark;
(Ashwell, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Sanofi-Aventis Deutschland GmBH |
Frankfurt am Main |
|
DE |
|
|
Family ID: |
1000005568555 |
Appl. No.: |
17/308831 |
Filed: |
May 5, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15579052 |
Dec 1, 2017 |
11027068 |
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PCT/EP2016/062447 |
Jun 2, 2016 |
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17308831 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2005/2013 20130101;
A61M 5/2033 20130101; A61M 5/3157 20130101; A61M 5/3204 20130101;
A61M 2205/581 20130101 |
International
Class: |
A61M 5/20 20060101
A61M005/20; A61M 5/315 20060101 A61M005/315 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 3, 2015 |
EP |
15170579.5 |
Claims
1. A syringe support (15, 15') for supporting an axial position of
a syringe (3) relative to a housing (2) of an autoinjector (1),
wherein the syringe support (15, 15') comprises: a supporting beam
(15.1) arranged on the syringe support (15, 15') and biased
radially inwards, wherein the supporting beam (15.1) is adapted to
axially bias the syringe (3) in a distal direction (D) within the
housing (2).
2. A syringe support (15, 15') according to claim 1, wherein the
supporting beam (15.1) is adapted to accommodate syringes (3)
having variable lengths (L) within the housing (2) in the distal
direction (D).
3. A syringe support (15, 15') according to claim 2, wherein the
supporting beam (15.1) is adapted to compensate variations in
length (L) of the syringe (3) of maximum of 5%.
4. A syringe support (15) according to any of the preceding claims,
wherein the supporting beam (15.1) is formed as a flexure beam.
5. A syringe support (15, 15') according to any of the preceding
claims, wherein one end of the supporting beam (15.1) is attached
to the syringe support (15, 15') and an opposite end is a free
end.
6. A syringe support (15, 15') according to claim 5, wherein at
least two supporting beams (15.1) are arranged on the syringe
support (15, 15').
7. A syringe support (15, 15') according to claim 5 or 6, wherein
the at least two supporting beams (15.1) are located distally on
the syringe support (15, 15').
8. A syringe support (15, 15') according to any of the claims 5 to
7, wherein the at least two supporting beams (15.1) have different
free ends wherein one of the free end is bent and the other free
end is straight.
9. Autoinjector (1) comprising: a syringe support (15, 15')
according to any one of the preceding claims, and a housing (2),
wherein the housing (2) comprises the syringe support (15,
15').
10. Autoinjector (1) according to claim 9, wherein the supporting
beam (15.1) and a flange (3.1) of the syringe (3) contact one
another and are pressed onto one another in an assembled state.
11. Autoinjector (1) according to claim 9 or 10, wherein the
syringe support (15, 15') comprises an aperture (15.2) in which the
supporting beam (15.1) is arranged.
12. Autoinjector (1) according to claim 11, wherein the supporting
beam (15.1) is biased radially inwards from the aperture
(15.2).
13. Autoinjector (1) according to any of the preceding claims 9 to
12, wherein the housing (2) comprises at least two rigid arms (2.3)
wherein each rigid arm (2.3) comprises one supporting beam
(15.1).
14. Autoinjector (1) according to any of the preceding claims 9 to
13, wherein the housing (2) comprises a front part (2.1) and a rear
part (2.2) and the supporting beam (15.1) is arranged distally on
the rear part (2.2).
15. Autoinjector (1) according to any of the preceding claims 9 to
14, wherein the housing (2) comprises a proximal end (2.4) which is
larger than a proximal aperture (2.6) of the housing (2).
16. Autoinjector (1) according to any of the preceding claims 9 to
15, wherein the syringe support (15, 15') comprises at least two
rigid arms (2.3, 15.3) extending in distal direction (D).
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 15/579,052, filed Dec. 1, 2017, which is the
national stage entry of International Patent Application No.
PCT/EP2016/062447, filed on Jun. 2, 2016, and claims priority to
Application No. EP 15170579.5, filed in on Jun. 3, 2015, the
disclosures of which are expressly incorporated herein in entirety
by reference thereto.
TECHNICAL FIELD
[0002] The disclosure relates to a syringe support and to an
autoinjector.
BACKGROUND
[0003] Administering an injection is a process which presents a
number of risks and challenges for users and healthcare
professionals, both mental and physical. Injection devices
typically fall into two categories--manual devices and
autoinjectors. In a conventional manual device, manual force is
required to drive a medicament through a needle. This is typically
done by a plunger which has to be continuously pressed during the
injection. There are numerous disadvantages associated with this
approach. For example, if the plunger is released prematurely, the
injection will stop and may not deliver an intended dose.
Furthermore, the force required to push the plunger may be too high
(e.g., if the user is elderly or a child). And, aligning the
injection device, administering the injection, and keeping the
injection device still during the injection may require dexterity
which some patients may not have.
[0004] Autoinjector devices may be single-use or reusable devices
and aim to make self-injection easier for patients. A conventional
autoinjector may completely or partially replace activities
involved in parenteral drug delivery from a manual device.
Typically, such activities include removal of a protective syringe
cap, insertion of the needle, providing the force for administering
the injection and possibly removal and shielding of the used
needle.
[0005] There remains a need for a syringe support within the
autoinjector and an improved autoinjector comprising such a syringe
support so that the autoinjector and its components, in particular
a syringe, are securely arranged within a housing.
SUMMARY
[0006] In some aspects, a syringe support and an improved
autoinjector with such a syringe support is provided.
[0007] Exemplary embodiments of the invention are given in the
dependent claims.
[0008] One aspect of the present disclosure relates to a syringe
support for supporting an axial position of a syringe relative to a
housing of an autoinjector, wherein the syringe support comprises a
supporting beam arranged on the syringe support and biased radially
inwards, wherein the supporting beam is adapted to axially bias the
syringe in a distal direction within the housing.
[0009] The syringe support provides a secure arrangement of the
syringe within the housing. In particular, the syringe support
allows tolerance compensation. For example, the syringe support
allows that syringes with different lengths due to manufacturing
tolerances may be arranged within the same housing. Furthermore,
the syringe support prevents rattle of the syringe in the housing
and at least reduces and prevents axial movement of the syringe
which otherwise could cause the protective needle shield to be
displaced relative to the syringe, potentially impacting
sterility.
[0010] In an exemplary embodiment, the supporting beam is adapted
to accommodate a variable length of the syringe within the housing
in the distal direction. In other words, the supporting beam
provides a secure arrangement by compensating different syringe
lengths. In particular, the supporting beam is adapted to
compensate the length of the syringe of maximum 5%, in particular
3%. For example, the syringe support accommodates +/-1.5 mm syringe
length for a syringe of 50 mm in length.
[0011] Additionally, for syringes with a smaller length, the
supporting beam may damp a shock of an impact force due to falling
so that the syringe is less prone to damages. For instance, due to
impact forces on an end of the autoinjector, the syringe moves
rearwards, a portion of the supporting beam deflects and further
stresses radially outwards so that the rearward movement of the
syringe can be absorbed, in particular damped and restricted.
[0012] In an exemplary embodiment, the supporting beam is located
distally on the syringe support. Thereby, the distal supporting
beam retains the syringe in position. Furthermore, more than one
supporting beams may be arranged around the circumference of the
syringe flange, thus the syringe is reliably held in position.
[0013] In an exemplary embodiment, the supporting beam is formed as
a flexure beam. In particular, the supporting beam is formed as a
radially inward half-arc or arc enabling the supporting beam to be
maintained in a relaxed position and to form a stop for the syringe
for compensating different syringe length. Furthermore, the
supporting beam may be stressed during assembling of the syringe
due to different length of the syringe to avoid or at least
minimize risk of damages. For instance, during assembling, the
syringe is carried and holds by a syringe carrier at its distal end
wherein the proximal end, namely the flange, of the syringe
projects the proximal end of the syringe carrier so that a portion
of the supporting beam, engaging the flange, deflects and further
stresses radially outwards so that the length of the syringe can be
compensated.
[0014] Furthermore, the supporting beam may be formed from
resilient material. In particular, the resilient supporting beam
could be in the form of an arc of resilient material, wherein at
least one end of the arc is attached to the housing and an outer
free end of the arc is in juxtaposition with the flange of the
syringe.
[0015] In a further embodiment, one end of the supporting beam is
attached to the syringe support and an opposite end is a free end.
In particular, the supporting beam is integrated into the syringe
support wherein the supporting beam extends radially inwards from a
recess or aperture in the syringe support so that the supporting
beam deflects radially outwards into the recess or aperture when
the syringe is assembled or moves rearwards. In an alternative
embodiment, both ends of the supporting beam may be attached to the
syringe support, e.g. to opposite ends of the aperture in the
syringe support. Such a supporting beam may be part of the syringe
support and may be integrated into the aperture as a bent or arc.
In particular, the supporting beam may be integrally moulded with
the syringe support for ease of manufacture.
[0016] Furthermore, the syringe support may comprise a number of
apertures adapted to form a corresponding number of supporting
beams that interact with the flange of the syringe for providing a
length compensation or a damping and a restricting of an axial
movement of smaller syringes rearwards when the syringe is
assembled and in place within the housing. Furthermore, the
supporting beams may be arranged around the circumference of the
syringe flange, thus the syringe is reliably held in position.
[0017] In a further embodiment, at least two supporting beams are
arranged on the syringe support. The at least two supporting beams
are arranged opposed to each other. More than two supporting beams
may be provided and may be symmetrically arranged on the syringe
support. Further, the at least two supporting beams are formed as
flexure beams, e.g. as a radially inward bent, for instance a
half-arc or arc.
[0018] In an exemplary embodiment, the at least two supporting
beams have different free ends wherein one of the free ends is bent
and the other free end is straight. In an assembled state of the
autoinjector, the different free ends of the supporting beams
laterally extend beyond the flange of the syringe. Hence, the
flange of the syringe abuts the different free ends. The different
free ends are adapted to provide a secure axial support and
positioning of the syringe relative to the housing in the rearward
direction. Thus, a risk of breakage is reduced. This increases the
range of geometrical syringe lengths that can be accommodated.
[0019] According to another aspect of the disclosure, an
autoinjector comprises a syringe support as described above and a
housing, wherein the housing comprises such a syringe support.
[0020] In an assembled state, the supporting beam and the flange of
the syringe contact one another and are pressed onto one another so
that the syringe is securely positioned.
[0021] In an exemplary embodiment, the housing comprises an
aperture in which the supporting beam is arranged. In particular,
the supporting beam is biased radially inwards from the
aperture.
[0022] In an exemplary embodiment, the housing comprises at least
two rigid arms wherein each rigid arm comprises one supporting
beam. In particular, the two rigid arms are formed as inner arms
which inwardly extend from an outer housing part, e.g. a proximal
end, into the housing.
[0023] In particular the housing comprises a front part and a rear
part wherein the supporting beam is arranged on the rear part. The
rear part comprises a proximal end from which the rigid arms are
inwardly extended. In this way, the supporting beam is arranged on
a distal end of the rear part.
[0024] Furthermore, the housing comprises a proximal end which is
larger than a proximal aperture of the housing. Thereby, the
proximal end of the rear part rests on the edge of the proximal
aperture of the front part to proximally close the housing.
[0025] Further scope of applicability of the present invention will
become apparent from the detailed description given hereinafter.
However, it should be understood that the detailed description and
specific examples, while indicating exemplary embodiments of the
invention, are given by way of illustration only, since various
changes and modifications within the spirit and scope of the
invention will become apparent to those skilled in the art from
this detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] The present invention will become more fully understood from
the detailed description given herein below and the accompanying
drawings which are given by way of illustration only, and thus, are
not limitative of the present invention, and wherein:
[0027] FIG. 1 is a schematic perspective partial section of an
exemplary embodiment of an autoinjector,
[0028] FIG. 2 is a schematic perspective view of an exemplary
embodiment of a housing part comprising a syringe support from an
inner end,
[0029] FIG. 3 is a schematic perspective view of an exemplary
embodiment of a housing part comprising a syringe support from a
proximal end,
[0030] FIG. 4 is a schematic perspective view of an exemplary
embodiment of a separate single syringe support and a separate
single rear part,
[0031] FIG. 5 is a schematic longitudinal section view of an
exemplary embodiment of a housing part having a syringe
support,
[0032] FIG. 6 is a schematic side view of a housing part having a
syringe support,
[0033] FIG. 7 is a schematic horizontal section view of an
exemplary embodiment of a housing part having a syringe
support,
[0034] FIG. 8 is a schematic side view of an exemplary embodiment
of a housing part having a syringe support,
[0035] FIGS. 9A to 9D are enlarged schematic views of an exemplary
embodiment of a syringe support in different states, and
[0036] FIG. 10 is an explosion view of a rear part and a front part
of a housing. Corresponding parts are marked with the same
reference symbols in all figures.
DETAILED DESCRIPTION
[0037] FIG. 1 is a schematic perspective partial section of an
exemplary embodiment of an autoinjector 1 in a state after
assembly.
[0038] The autoinjector 1 comprises a housing 2 including a sleeve
shaped front part 2.1 and a rear part 2.2. Alternatively, the
housing 2 may be formed as a one-piece housing (not shown).
[0039] The housing 2 is adapted to hold a syringe 3, e.g. a glass
syringe. The syringe 3 may be a pre-filled syringe containing a
liquid medicament M and have a needle 4 arranged on a distal end.
In another exemplary embodiment, the syringe 3 may be a cartridge
which includes the medicament M and engages a removable needle
(e.g., by threads, snaps, friction, etc.). In the shown exemplary
embodiment, the syringe 3 is held in the housing 2 and supported at
its proximal end therein by a syringe support 15 further described
below.
[0040] The autoinjector 1 further comprises a protective needle
sheath 5 that is coupled to the needle 4. For example, the
protective needle sheath 5 is removably coupled to the needle 4.
The protective needle sheath 5 may be a rubber needle sheath or a
rigid needle sheath which is composed of rubber and a full or
partial plastic shell.
[0041] A stopper 6 is arranged for sealing the syringe 3 in a
proximal direction P and for displacing the medicament M contained
in the syringe 3 through the needle 4.
[0042] The autoinjector 1 further comprises a sleeve shaped needle
shroud 7. In an exemplary embodiment, the needle shroud 7 is
telescopically coupled to the housing 2 and movable between an
extended position relative to the housing 2 in which the needle 4
is covered and a retracted position relative to the housing 2 in
which the needle 4 is exposed. Furthermore, a shroud spring 8 is
arranged to bias the needle shroud 7 in a distal direction D
against the housing 2.
[0043] A drive spring 9 in the shape of a compression spring is
arranged within a proximal part of the housing 2, in particular the
rear part 2.2. A plunger 10 serves for forwarding the force of the
drive spring 9 to the stopper 6. In an exemplary embodiment, the
plunger 10 is hollow and the drive spring 9 is arranged within the
plunger 10, biasing the plunger 10 in the distal direction D
against the rear part 2.2. In another exemplary embodiment, the
plunger 10 may be solid and the drive 9 may engage a proximal end
of the plunger 10. Likewise, the drive spring 9 could be wrapped
around the outer diameter of the plunger 10 and extend within the
syringe 3.
[0044] Furthermore, the autoinjector 1 comprises a cap 11 that may
be removably disposed at a distal end of the housing 2, in
particular at a distal end of the front part 2.1. The cap 11 may
comprise grip features 11.1 for facilitating removal of the cap 11,
e.g., by twisting and/or pulling the cap 11 off the case 2. The cap
11 may further include a grip element 11.2, e.g., a barb, a hook, a
narrowed section, etc., arranged to engage the protective needle
sheath 5, the housing 2 and/or the needle shroud 7. For example,
the protective needle sheath 5 is coupled to the cap 11 in a manner
that when the cap 11 is removed, the protective needle sheath 5 is
also removed from the needle 4.
[0045] A plunger release mechanism 12 is arranged for preventing
release of the plunger 10 prior to depression of the needle shroud
7 and for releasing the plunger 10 once the needle shroud 7 is
sufficiently depressed.
[0046] In an exemplary embodiment, the autoinjector 1 further
comprises at least one audible indicator 13 for producing an
audible feedback for a user or patient indicating that medicament
delivery is complete. In other words: The audible indicator 13 is
adapted to indicate to a user or a patient that the full dose of
medicament M was spent. The audible indicator 13 is formed for
example as a bistable spring and is held in the rear part 2.2.
[0047] To allow an accurate support of the syringe 3 during and
after assembly, the autoinjector 1 comprises a carrier 16 adapted
to mount and hold the syringe 3 within the housing 2 in a forward
or distal direction D.
[0048] A shroud pre-lock mechanism 14 is arranged to prevent
depression of the needle shroud 7 when the cap 11 is in place, thus
avoiding unintentional activation of the autoinjector 1, e.g. if
dropped, during shipping or packaging, etc.
[0049] Due to manufacturing tolerance, syringes 3 may have variable
lengths L. Thus, a flange 3.1 of the syringe 3 protrudes the
carrier 16 in the proximal direction P. To support the axial
position of the syringe 3 relative to the housing 2 after assembly,
in particular during storage, transportation and normal use, the
syringe support 15 comprises one or more supporting beams 15.1
biased radially inwards to accommodate the variable length L of the
syringe 3 in an assembled state. The supporting beams 15.1 are
adapted to axially bias the syringe 3 in the distal direction D
within the housing 2 and to compensate the variable length L of the
syringe 3 in the distal direction D. In particular, the syringe
support 15 is adapted to accommodate the length L of the syringe 3
of maximum 5% or 3%. For example, the syringe support 15
accommodates +/-1.5 mm of the length L for a syringe 3 of 50 mm in
length L.
[0050] FIGS. 2 and 3 are schematic views of the rear part 2.2 of
the housing 2. The rear part 2.2 comprises the syringe support 15.
The syringe support 15 is adapted to compensate the variable length
L of the syringe 3. In detail, the rear part 2.2 comprises at its
front or distal end the supporting beams 15.1. The supporting beams
15.1 are formed as resilient arms or flexure beams biased radially
inwards to compensate the variable lengths L of the syringe 3.
[0051] In the shown embodiment, the rear part 2.2 has a proximal
end 2.4. The proximal end 2.4 of the rear part 2.2 is larger than a
proximal aperture 2.6 so that the proximal end 2.4 rests on the
edge of the proximal aperture 2.6 of the front part 2.1. Two rigid
arms 2.3 are extended from the proximal end 2.4 inwards in to the
distal direction D.
[0052] The shown syringe support 15 comprises two supporting beams
15.1 and a respective number of apertures 15.2 in the rigid arms
2.3. The apertures 15.2 are adapted to receive each of the
supporting beams 15.1 when they deflect and stress radially
outwards during assembling of the syringe 3 having a variable
length L.
[0053] The supporting beams 15.1 and the corresponding apertures
15.2 are arranged on a distal end of the rear part 2.2.
[0054] The supporting beams 15.1 may be formed from resilient
material and in the form of an arc or half-arc.
[0055] One end of each supporting beams 15.1 is attached to the
aperture 15.2 in the rear part 2.2. The opposite end is a free end.
Each supporting beam 15.1 extends radially inwards from the
aperture 15.2 so that the supporting beam 15.1 deflects radially
outwards into the aperture 15.2 when a syringe 3 with a respective
length L is assembled into the syringe carrier 16 and the flange
3.1 of the syringe 3 protrudes the syringe carrier 16 in the
proximal direction P. In particular, the supporting beams 15.1 may
be integrally moulded with the housing 2, namely with the rear part
2.2.
[0056] In an alternative embodiment (not shown), both ends of the
supporting beam may be attached to the housing.
[0057] Furthermore, the rear part 2.2 comprises a housing lock 17
having a housing lock arm 17.1 to attach the rear part 2.2 onto the
front part 2.1. The housing lock arm 17.1 is arranged on a proximal
section of the rear part 2.2 and is biased radially outwards.
[0058] FIG. 4 shows an alternative embodiment of a syringe support
15' formed as a separate single part and the rear part 2.2 formed
as a separate single part. The syringe support 15' has a proximal
support end 15.3 from which rigid support arms 15.4 comprising the
supporting beams 15.1 distally protrude. The proximal support end
15.3 and the housing 2, in particular the front part 2.1 or the
rear part 2.2, are correspondingly adapted to retain and hold the
syringe support 15' in place on the housing 2, e.g. by securing a
rim in a nut or in clips on the housing (shown in dotted line).
[0059] The separate rear part 2.2 only comprises the housing lock
17 for releasably connecting the rear part 2.2 with the front part
2.1 to form the housing 2.
[0060] FIG. 5 is a schematic longitudinal section view of the rear
part 2.2. The FIG. 5 shows the rear part 2.2 with one supporting
beam 15.1 that are part of the syringe support 15. The supporting
beam 15.1 is arranged on a distal section of the rear part 2.2 and
is biased radially inwards.
[0061] The housing lock arms 17.1 attach the rear part 2.2 onto the
front part 2.1. The housing lock arms 17.1 are proximally arranged
on the rear part 2.2 and are biased radially outwards. The housing
lock arms 17.1 retain the rear part 2.2 in position with the front
part 2.1.
[0062] FIG. 6 is a schematic side view of the rear part 2.2
comprising the syringe support 15. To guide the rear part 2.2
during assembling and to support it after assembling and during
use, the rear part 2.2 comprises an inner stamp 2.5. The inner
stamp 2.5 further supports the assembling and arrangement of the
drive spring 9 (see FIG. 1).
[0063] FIG. 7 is a schematic horizontal section view of the syringe
support 15 according to line VI-VI in FIG. 5. The free ends of the
supporting beams 15.1 are biased radially inwards with respect to
the rigid arms 2.3.
[0064] FIG. 8 is a schematic side view of the rear part 2.2 with
the supporting beam 15.1 attached to the aperture 15.2 and arranged
on the distal end of the rear part 2.2. The distal end of the
supporting beam 15.1 is attached to the aperture 15.2 and the
proximal end of the supporting beam 15.1 is formed as a free end
biased radially inwards.
[0065] FIGS. 9A to 9D are enlarged schematic views of the syringe
support 15 formed as part of the rear part 2.2. The syringe support
15 is shown in different positions and in more detail.
[0066] FIG. 9A shows the syringe support 15 while the syringe 3
with a normal length L is in an assembled position.
[0067] The at least two supporting beams 15.1 have different free
ends wherein one of the free ends is bent and the other free end is
straight. The free ends of the arcs of the supporting beams 15.1
are in juxtaposition with the flange 3.1 of the syringe 3.
[0068] Furthermore, the different free ends of the supporting beams
15.1 laterally extend beyond a flange 3.1 of the syringe 3. The
flange 3.1 abuts the supporting beams 15.1 and the different free
ends to provide a secure axial support and positioning of the
syringe 3 relative to the housing 2 in the distal direction D.
Syringes 3 having variable lengths L may be assembled within the
housing 2 wherein the supporting beam 15.1 is deflected radially
outwards and stressed so that the variable lengths L of the
syringes 3 can be compensated. Hence, a risk of breakage is reduced
and manufacturing tolerances may be compensated.
[0069] In the shown embodiment, the supporting beams 15.1 are
arranged between the flange 3.1 of the syringe 3 and the front part
2.1 of the housing 2.
[0070] FIGS. 9B to 9D shows further embodiments for the syringe
support 15 with assembled syringes 3 of different lengths L. Hence,
the syringe support 15 allows compensation of length tolerances of
syringes 3 to be assembled.
[0071] FIG. 10 shows the front part 2.1 and the rear part 2.2 of
the housing. The front part 2.1 and the rear part 2.2 are
correspondingly adapted to couple with each other, e.g. by means of
a releasable connection formed by e.g. the housing locking arms
17.1 and corresponding slots 2.7.
[0072] The terms "drug" or "medicament" are used herein to describe
one or more pharmaceutically active compounds. As described below,
a drug or medicament can include at least one small or large
molecule, or combinations thereof, in various types of
formulations, for the treatment of one or more diseases. Exemplary
pharmaceutically active compounds may include small molecules;
polypeptides, peptides and proteins (e.g., hormones, growth
factors, antibodies, antibody fragments, and enzymes);
carbohydrates and polysaccharides; and nucleic acids, double or
single stranded DNA (including naked and cDNA), RNA, antisense
nucleic acids such as antisense DNA and RNA, small interfering RNA
(siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may
be incorporated into molecular delivery systems such as vectors,
plasmids, or liposomes. Mixtures of one or more of these drugs are
also contemplated.
[0073] The term "drug delivery device" shall encompass any type of
device or system configured to dispense a drug into a human or
animal body. Without limitation, a drug delivery device may be an
injection device (e.g., syringe, pen injector, auto injector,
large-volume device, pump, perfusion system, or other device
configured for intraocular, subcutaneous, intramuscular, or
intravascular delivery), skin patch (e.g., osmotic, chemical,
micro-needle), inhaler (e.g., nasal or pulmonary), implantable
(e.g., coated stent, capsule), or feeding systems for the
gastro-intestinal tract. The presently described drugs may be
particularly useful with injection devices that include a needle,
e.g., a small gauge needle.
[0074] The drug or medicament may be contained in a primary package
or "drug container" adapted for use with a drug delivery device.
The drug container may be, e.g., a cartridge, syringe, reservoir,
or other vessel configured to provide a suitable chamber for
storage (e.g., short- or long-term storage) of one or more
pharmaceutically active compounds. For example, in some instances,
the chamber may be designed to store a drug for at least one day
(e.g., 1 to at least 30 days). In some instances, the chamber may
be designed to store a drug for about 1 month to about 2 years.
Storage may occur at room temperature (e.g., about 20.degree. C.),
or refrigerated temperatures (e.g., from about -4.degree. C. to
about 4.degree. C.). In some instances, the drug container may be
or may include a dual-chamber cartridge configured to store two or
more components of a drug formulation (e.g., a drug and a diluent,
or two different types of drugs) separately, one in each chamber.
In such instances, the two chambers of the dual-chamber cartridge
may be configured to allow mixing between the two or more
components of the drug or medicament prior to and/or during
dispensing into the human or animal body. For example, the two
chambers may be configured such that they are in fluid
communication with each other (e.g., by way of a conduit between
the two chambers) and allow mixing of the two components when
desired by a user prior to dispensing. Alternatively or in
addition, the two chambers may be configured to allow mixing as the
components are being dispensed into the human or animal body.
[0075] The drug delivery devices and drugs described herein can be
used for the treatment and/or prophylaxis of many different types
of disorders. Exemplary disorders include, e.g., diabetes mellitus
or complications associated with diabetes mellitus such as diabetic
retinopathy, thromboembolism disorders such as deep vein or
pulmonary thromboembolism. Further exemplary disorders are acute
coronary syndrome (ACS), angina, myocardial infarction, cancer,
macular degeneration, inflammation, hay fever, atherosclerosis
and/or rheumatoid arthritis.
[0076] Exemplary drugs for the treatment and/or prophylaxis of
diabetes mellitus or complications associated with diabetes
mellitus include an insulin, e.g., human insulin, or a human
insulin analogue or derivative, a glucagon-like peptide (GLP-1),
GLP-1 analogues or GLP-1 receptor agonists, or an analogue or
derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a
pharmaceutically acceptable salt or solvate thereof, or any mixture
thereof. As used herein, the term "derivative" refers to any
substance which is sufficiently structurally similar to the
original substance so as to have substantially similar
functionality or activity (e.g., therapeutic effectiveness).
[0077] Exemplary insulin analogues are Gly(A21), Arg(B31), Arg(B32)
human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin;
Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human
insulin, wherein proline in position B28 is replaced by Asp, Lys,
Leu, Val or Ala and wherein in position B29 Lys may be replaced by
Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27)
human insulin and Des(B30) human insulin.
[0078] Exemplary insulin derivatives are, for example,
B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30)
human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human
insulin; B28-N-myristoyl LysB28ProB29 human insulin;
B28-N-palmitoyl-LysB28ProB29 human insulin;
B30-N-myristoyl-ThrB29LysB30 human insulin;
B30-N-palmitoyl-ThrB29LysB30 human insulin;
B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin;
B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin;
B29-N-(.omega.-carboxyheptadecanoyl)-des(B30) human insulin and
B29-N-(.omega.-carboxyheptadecanoyl) human insulin. Exemplary
GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for
example: Lixisenatide/AVE0010/ZP10/Lyxumia,
Exenatide/Exendin-4/Byetta/Bydureon/ITCA 650/AC-2993 (a 39 amino
acid peptide which is produced by the salivary glands of the Gila
monster), Liraglutide/Victoza, Semaglutide, Taspoglutide,
Syncria/Albiglutide, Dulaglutide, rExendin-4, CJC-1134-PC, PB-1023,
TTP-054, Langlenatide/HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901,
NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1,
ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022,
TT-401, BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255,
Exenatide-XTEN and Glucagon-Xten.
[0079] An exemplary oligonucleotide is, for example:
mipomersen/Kynamro, a cholesterol-reducing antisense therapeutic
for the treatment of familial hypercholesterolemia.
[0080] Exemplary DPP4 inhibitors are Vildagliptin, Sitagliptin,
Denagliptin, Saxagliptin, Berberine.
[0081] Exemplary hormones include hypophysis hormones or
hypothalamus hormones or regulatory active peptides and their
antagonists, such as Gonadotropine (Follitropin, Lutropin,
Choriongonadotropin, Menotropin), Somatropine (Somatropin),
Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin,
Buserelin, Nafarelin, and Goserelin.
[0082] Exemplary polysaccharides include a glucosaminoglycane, a
hyaluronic acid, a heparin, a low molecular weight heparin or an
ultra-low molecular weight heparin or a derivative thereof, or a
sulphated polysaccharide, e.g. a poly-sulphated form of the
above-mentioned polysaccharides, and/or a pharmaceutically
acceptable salt thereof. An example of a pharmaceutically
acceptable salt of a poly-sulphated low molecular weight heparin is
enoxaparin sodium. An example of a hyaluronic acid derivative is
Hylan G-F 20/Synvisc, a sodium hyaluronate.
[0083] The term "antibody", as used herein, refers to an
immunoglobulin molecule or an antigen-binding portion thereof.
Examples of antigen-binding portions of immunoglobulin molecules
include F(ab) and F(ab').sub.2 fragments, which retain the ability
to bind antigen. The antibody can be polyclonal, monoclonal,
recombinant, chimeric, de-immunized or humanized, fully human,
non-human, (e.g., murine), or single chain antibody. In some
embodiments, the antibody has effector function and can fix
complement. In some embodiments, the antibody has reduced or no
ability to bind an Fc receptor. For example, the antibody can be an
isotype or subtype, an antibody fragment or mutant, which does not
support binding to an Fc receptor, e.g., it has a mutagenized or
deleted Fc receptor binding region.
[0084] The terms "fragment" or "antibody fragment" refer to a
polypeptide derived from an antibody polypeptide molecule (e.g., an
antibody heavy and/or light chain polypeptide) that does not
comprise a full-length antibody polypeptide, but that still
comprises at least a portion of a full-length antibody polypeptide
that is capable of binding to an antigen. Antibody fragments can
comprise a cleaved portion of a full length antibody polypeptide,
although the term is not limited to such cleaved fragments.
Antibody fragments that are useful in the present disclosure
include, for example, Fab fragments, F(ab')2 fragments, scFv
(single-chain Fv) fragments, linear antibodies, monospecific or
multispecific antibody fragments such as bispecific, trispecific,
and multispecific antibodies (e.g., diabodies, triabodies,
tetrabodies), minibodies, chelating recombinant antibodies,
tribodies or bibodies, intrabodies, nanobodies, small modular
immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion
proteins, camelized antibodies, and VHH containing antibodies.
Additional examples of antigen-binding antibody fragments are known
in the art.
[0085] The terms "Complementarity-determining region" or "CDR"
refer to short polypeptide sequences within the variable region of
both heavy and light chain polypeptides that are primarily
responsible for mediating specific antigen recognition. The term
"framework region" refers to amino acid sequences within the
variable region of both heavy and light chain polypeptides that are
not CDR sequences, and are primarily responsible for maintaining
correct positioning of the CDR sequences to permit antigen binding.
Although the framework regions themselves typically do not directly
participate in antigen binding, as is known in the art, certain
residues within the framework regions of certain antibodies can
directly participate in antigen binding or can affect the ability
of one or more amino acids in CDRs to interact with antigen.
[0086] Exemplary antibodies are anti PCSK-9 mAb (e.g., Alirocumab),
anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g.,
Dupilumab).
[0087] The compounds described herein may be used in pharmaceutical
formulations comprising (a) the compound(s) or pharmaceutically
acceptable salts thereof, and (b) a pharmaceutically acceptable
carrier. The compounds may also be used in pharmaceutical
formulations that include one or more other active pharmaceutical
ingredients or in pharmaceutical formulations in which the present
compound or a pharmaceutically acceptable salt thereof is the only
active ingredient. Accordingly, the pharmaceutical formulations of
the present disclosure encompass any formulation made by admixing a
compound described herein and a pharmaceutically acceptable
carrier.
[0088] Pharmaceutically acceptable salts of any drug described
herein are also contemplated for use in drug delivery devices.
Pharmaceutically acceptable salts are for example acid addition
salts and basic salts. Acid addition salts are e.g. HCl or HBr
salts. Basic salts are e.g. salts having a cation selected from an
alkali or alkaline earth metal, e.g. Na+, or K+, or Ca2+, or an
ammonium ion N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of
each other mean: hydrogen, an optionally substituted C1-C6-alkyl
group, an optionally substituted C2-C6-alkenyl group, an optionally
substituted C6-C10-aryl group, or an optionally substituted
C6-C10-heteroaryl group. Further examples of pharmaceutically
acceptable salts are known to those of skill in the arts.
[0089] Pharmaceutically acceptable solvates are for example
hydrates or alkanolates such as methanolates or ethanolates.
[0090] Those of skill in the art will understand that modifications
(additions and/or removals) of various components of the
substances, formulations, apparatuses, methods, systems and
embodiments described herein may be made without departing from the
full scope and spirit of the present invention, which encompass
such modifications and any and all equivalents thereof.
LIST OF REFERENCES
[0091] autoinjector [0092] 2 housing [0093] 2.1 front part [0094]
2.2 rear part [0095] 2.3 rigid arm [0096] 2.4 proximal end [0097]
2.5 stamp [0098] 2.6 proximal aperture [0099] 2.7 slot [0100] 3
syringe [0101] 3.1 flange [0102] 4 needle [0103] 5 protective
needle sheath [0104] 6 stopper [0105] 7 needle shroud [0106] 8
shroud spring [0107] 9 drive spring [0108] 10 plunger [0109] 11 cap
[0110] 11.1 grip feature [0111] 11.2 grip element [0112] 12 plunger
release mechanism [0113] 13 audible indicator [0114] 14 shroud
pre-lock mechanism [0115] 15 syringe support [0116] 15.1 supporting
beam [0117] 15.2 aperture [0118] 15.3 proximal support end [0119]
15.4 rigid support arm [0120] 16 carrier [0121] 17 housing lock
[0122] 17.1 housing lock arm [0123] D distal direction [0124] L
length [0125] M medicament
* * * * *